The Role of Quality and Quality Management Systems in Telemedicine

Harald Korb

Chief Medical Officer
Vitaphone GmbH
Mannheim
Germany.

Markus Lindlar

M German Aerospace Center
Institute of Aerospace Medicine

To secure and demonstrate quality of their processes a growing number of providers of medical care establish quality management systems (QMS) following international quality standards like e.g. EN ISO 9001:2008. Telemedical services following these quality standards are rare as results of a literature research showed in 2009. The article demonstrates study results and first promising activities on the field.

The proof of quality very often is a precondition requested by principals prior to concluding a contract or to place an order. Quality of services and or products gains in importance not only in the medical sector; this applies to products, services produced or provided by companies or service providers as well. Quality is defined as the conformance with requirements usually defined by the customers themselves. In the healthcare sector, products include medical devices or pharmaceutical drugs. Medical services include medical examinations or (tele)-medical applications. The main services or core processes of hospitals which in general are medical service providers are diagnostics, treatment and rehabilitation. The level of quality of these services corresponds to the grade of customer retention. The better the service quality more the patients return to the hospital the next time medical support is needed.

To provide objective evidence of product or service quality more and more health care providers on various medical fields have established Quality Management Systems (QMS). In particular, EN ISO 9001:2008 certified QMS are widespread in hospitals, doctor's practices or in companies producing medical devices. In Germany, providers of medical care are committed to implement QMS and to improve them continuously starting 2010.

Regarding the evolving role of telemedicine in the healthcare system worldwide and its claim to deliver at least equivalent or better quality than the standard non-telemedical services, it should be expected that quality and quality management systems are already considered when developing products or services.

The Institute of Aerospace Medicine of the German Aerospace Center addressed this topic in 2008 conducting a survey searching the databases of PubMed and the Telemedicine Information Exchange (TIE) to gain an overview of the role of quality in general and especially of quality management systems in the field of telemedicine with focus on telemonitoring. Catchwords in this research were "Telemedicine or Telehealth or E-Health or Telemonitoring" in combination with "Quality" and "Certification or Guidelines or Pathways or Management or ISO 9001"

Only 202 publications matched the search criteria; 141 were found on the PubMed portal of the U.S. National Library of Medicine. In the database of the Telemedicine Information Exchange; 61 publications matched the query. Among these, 108 publications described studies about new applications or limited projects; 72 publications analysed established services in the field of patient care. The topics of 22 papers were neither studies nor running services; 35 publications dealt with quality aspects of telemedical applications. The papers of 20 telemedical services reported to be integrated in patient care discussed quality aspects.

But only two different publications described a teleradiological application certified as EN ISO 9001:2000. Unfortunately, these publications belonged to one and the same application. One publication described a QMS following the Six Sigma standard which is however focusing more on quality management systems on the manufacturing than on the service field.

These results were unexpected and a first superficial analysis of the results could lead to the assumption that QMS do not play a significant role for telemedicine service providers.

But that interpretation could miss some facts. QMS cover companies, not services. Thus, telemedical services could be just one part of a complex product portfolio offered by a company which could run a QMS including all the telemedical and non-telemedical processes. But keeping in mind the spread of QMS not just in the medical sector, a few references to QMS of the publishing institutions would be present in the corresponding papers. It has been very surprising that only two publications of established telemedical services describe the embedding in a QMS.

Yet a distortion of results could be caused by the study's design. In fact, several scientific publications are published in an early stage of development of a telemedical application. QMS very often are established when services are already operational. For this reason the study focused on well established telemedical applications. But an additional random research in the Worldwide Web delivered a trend similar to PubMed and TIE research. Summing up the results of the study, quality management systems did not play a similar role in telemedicine as they did in other sectors of medical care or medical business in general at the time of study performance.

But the demographic development in Europe with the growing number of elderly, and very often chronically ill people, and the lack of resources for medical care, especially in the outpatient sector, have created a growing need for telemedical services to deliver medical care. Thus in 2008 Germany and Europe initiated research programmes to support the development of Ambient Assisted Living (AAL) services for senior and/or chronically ill citizens.

AAL is the support for people in their personal environment by technologies and services in the fields of medical care, safety, social integration and supply with convenience goods. The majority of AAL-conceptions or of telemonitoring supported programmes for the chronically ill are based on the collection and transmission of biological signals from the domotic, medical and social field, whereby the focus is mainly set on the technical implementation with all inherent problems. Due to the fixation on technical details, a decisive aspect is largely ignored: where is the obtained information collected, concentrated and interpreted, and who triggers after this initial analysis which reactions based on clear juridical backgrounds and responsibilities? A putative solution is provided by a centralised Telemedical Service Center (TSC), which must, however, fulfill all prerequisites of a quality-assured information and service platform as part of the interconnected network of customer / patient, healthcare partner, care and medical technology.

Many planners and operators of TSCs are sometimes overstrained with the complexity of their IT systems. Therefore, it seemed necessary to set up a Quality Management System framework dedicated to the needs of a TSC. The Working Group “Quality Management”, commissioned by the VDE-Initiative MicroMedicine committee “Telemedicine / Disease Management” in VDE / DGBMT has defined standards derived from DIN EN ISO 9000:2000, DIN EN ISO 9001 and DIN EN ISO 13485 and other relevant legislations for the application of telemonitoring systems and implemented a quality management system for telemedical service centers. The result was the VDE application "Telemonitoring", which is a practical reference work of high quality. In addition to the comprehensive definition of terms and detailed description of telemedical resources, requirements for personnel qualifications, structures and processes, it provides a complete overview of the relevant legal standards. The new VDE application defines the quality requirements for the provision of telemedical services and internal processes, but also the necessary hardware and the secure transfer of data from the domestic area of the patient to the TSC, clinic or doctor's office. Thus patient data cannot be disclosed to any third party. Given a consistent application a misuse of sensitive personal data and findings is virtually impossible. The VDE Test and Certification Institute successfully used it as a reference for the certification of TSCs.

Under the background of growing internet connectivity in private homes and ubiquitous cost pressure in healthcare, TSCs offer an efficient complement to established services in chronic disease management. The TSC acts as the general contractor of an extremely complex structure. Apart from the provision of hard- and software for the home environment, installation of data communication between patient, TSC and specialist, efficient organisational set-up, the management of sensitive patient data and the related data safety aspects are the major challenges. Due to the high level of complexity, TSCs are looking for independent third party assistance to get confirmation of their legal compliance and fulfillment of customer needs. Besides these aspects, third party evaluation has several benefits. One is assistance to involve employees from all hierarchical levels and functions in order to install a process of continuous improvement as the vital part of the QMS. Another is supporting the top management in the penetration of the concept by regularly reviewing its effectiveness and helping to adopt the quality strategy accordingly. Furthermore, the QMS sets the framework for auditing and certification, which adds two more aspects: enlargement of scope and formal acceptance. Scope enlargement comes from the interaction and discussions with the auditors, having a fundamental background from the industry and, therefore, efficiently guiding the organisation towards reasonable modifications and optimisations of their QMS. Finally, formal acceptance by certification gives credit to all people involved and motivates for continued commitment of resources.

The review looks to safeguard confidential patient data is one of the most relevant topics during the audits. In addition to hierarchically restricted access for patients, doctors and administrative staff, the software structure is in focus. Data safety handling of external subcontractors, either for health & care, outsourced IT or any other services will be included as well as review of intermediate storage or long-term in archives in juke boxes, on tape or WORM. Whether data safety is an integral and essential part of the risk management scheme, and whether the risk levels are properly addressed and corrective action plans are in place will be monitored. Scenarios of data loss, data recovery or data fraud are covered as well.

Nevertheless, the focal point is always the patient. Comprehensive information about the content of the services provided, formal authorisation before any transfer of confidential patient data to third party and regular customer satisfaction surveys are key requirements of a QMS.

Third party auditing and certification of the system, give a measurable value added to the performance of TSC. Safeguarding legal compliance with priority on data safety, cost effectiveness, involvement of employees and customer satisfaction will be key ingredients to fulfill the needs of all stakeholders in telemonitoring applications. Adequate management of these topics will foster both public acceptance and penetration of these services and – in consequence – making life of chronic disease patients a little bit easier.

Finally, it must be stated that QMS still do not but start to play an important role in telemedicine, especially with focus on telemonitoring and AAL to guarantee quality of services on one hand. On the other hand QMS at present are a unique selling point for healthcare providers to convince contractors of the quality of their telemedical services.

Author Bio

Markus Lindlar is a physician who studied medicine in Italy and Germany and specialised in medical informatics in 2001. Focus of his work at the German Aerospace Center is telemedicine and e-health with focus on health economics and service quality. He is board member of the German Society of Health Telematics – DGG

Professor Harald Korb is one of the leading experts in the field of telemedicine providing of more than 10 years in experience in the monitoring of patients with cardiac disorders. Prof. Korb is vice president of the German Society of Health Telematics – DGG and member and speaker in numerous medical associations, advisory boards and executive committees.